Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8

Recall Number: D-1207-2018

Firm: Noven Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20181003

Initiation Date: 20180907

Termination Date: 20200909

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8